Pulsed Field Ablation for Atrial Fibrillation Under General Anesthesia Versus Remimazolam-based Deep Sedation

Real-world evidence indicates that deep sedation is the predominant anesthesia strategy for pulsed field ablation (PFA) in most European centers, whereas general anesthesia remains the standard of care in China. Given disparities in anesthesiologist availability and fundamental differences in healthcare system infrastructure and workflow organization, establishing an electrophysiologist-led deep sedation pathway has the potential to streamline PFA procedural logistics, enhance perioperative patient comfort, and facilitate the standardized, scalable, and sustainable implementation of this novel technology. This study aims to determine whether pulmonary vein isolation (PVI) performed with PFA under a remimazolam-based deep sedation protocol is non-inferior to PVI under general anesthesia in terms of both safety and efficacy among patients with atrial fibrillation (AF).

Inclusion Criteria: 1. At the time of enrollment, the legal age is ≥ 18 years old; 2. Patients with non-valvular atrial fibrillation who have indications for atrial fibrillation ablation; 3. Intend to receive atrial fibrillation ablation for the first time; 4. Able to provide informed consent, willing to participate in follow-up visits and provide relevant information. Exclusion Criteria: 1. Secondary atrial fibrillation due to electrolyte imbalance or other reversible or non-cardiac causes; 2. Contraindications to PFA procedure, anticoagulant drugs or anesthetic drugs; 3. Acute myocardial infarction or stroke within 3 months; 4. Heart Failure subjects with NYHA III/IV or LVEF \< 40%; 5. BMI ≥ 35 kg/m²; 6. Sleep apnea syndrome, or anticipated airway difficulty; 7. COPD GOLD III/IV grade, severe asthma and other respiratory diseases; 8. Clinical conditions assessed by the investigator as unsuitable for deep sedation, such as high reflux and high aspiration risk; 9. Clinical conditions assessed by the investigator as intolerant to the procedure, such as severe liver and kidney dysfunction.